Molecular Determinants of Spinal Cord Injury Rehabilitation

NCT07383077 | Completed

• 2 other identifiers: ProTmedula 246/2019-2 SAcu-ChrNCT06892106 ClinicalTrials.gov
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This study main aim is to identify molecular determinants of better recovery following spinal cord injury (SCI), as biomarkers of neurological and/or functional improvement and a proxy for neuroregeneration. For that, omics analyses of several biological samples will be performed, to comprehensively portray the molecular and cellular profiles of the patients with SCI at key time points of the pathology: pre-rehabilitation, post-rehabilitation and one-year post-injury. The main question it aims to answer is: 'Are there specific molecules (and related biological pathways) that impact the functional recovery of spinal cord injury patients during the subacute phase, in a way that future targeted pharmacological or genetic interventions may improve SCI outcomes?'.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Rehabilitation; Regeneration; Omics; Biomarkers; Therapeutic targets; Translational

Outcome Measures

Primary Outcomes (2)

• Molecular/cellular candidate biomarkers with a strong association to functional independence

  Association between functional independence, assessed by the Spinal Cord Independence Measure, 4th version (SCIM IV), and by the Functional Independence Measure (FIM), with levels of specific molecular or cellular candidate biomarkers. Association studies will consider functional independence measures (at admission, their variation, and/or at discharge) and specific molecular or cellular candidate biomarkers, such as protein or bacterial levels (at admission, their variation, and/or at discharge).

  From admission into the rehabilitation hospital (~2 months post-injury) until discharge (~4 months post-injury)

• Molecular/cellular candidate biomarkers with a strong association to neuromotor impairment

  Association between total motor scores, assessed by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), with levels of specific molecular or cellular candidate biomarkers. Association studies will consider ISNCSCI motor scores (at admission, their variation, and/or at discharge) and specific molecular or cellular candidate biomarkers, such as protein or bacterial levels (at admission, their variation, and/or at discharge).

  From admission into the rehabilitation hospital (~2 months post-injury) until discharge (~4 months post-injury)

Secondary Outcomes (2)

• Molecular/cellular candidate biomarkers identified in the primary outcome measures with a strong association to neurological impairment

  From admission into the rehabilitation hospital (~2 months post-injury), across discharge (~4 months post-injury), and until follow-up (1-year post-injury)

• Longitudinal profiles of key molecules (and bacteria) across post-intensive inpatient rehabilitation, and a period post-discharge (subacute and chronic phases)

  From admission into the rehabilitation hospital (~2 months post-injury), across discharge (~4 months post-injury), and until follow-up (1-year post-injury)

Study Arms (2)

SCI cohort

Spinal cord injury patients admitted for hospitalization at Centro de Reabilitação do Norte, Unidade Local de Saúde de Gaia e Espinho, E.P.E. categorized into two subgroups: with A or B (motor complete injuries) classification, or with C or D (motor incomplete) classification in The American Spinal Injury Association (ASIA) Impairment Scale (AIS).

Able-bodied controls

Age, sex and body mass index-matched control group of participants recruited among able-bodied personnel from Centro de Reabilitação do Norte, Unidade Local de Saúde de Gaia e Espinho, E.P.E. or their relatives, without any known CNS disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the North Rehabilitation Center ("Centro de Reabilitação do Norte, CRN-ULSGE") between 1st of May 2021 and 16th of October 2023, following a traumatic spinal cord injury.

You may qualify if:

• Clinically diagnosed with traumatic spinal cord injury
• Adults (≥18 years).
• Injury occurred less than 6 months ago (subacute phase).
• Classification A-D in The American Spinal Injury Association (ASIA) Impairment Scale (AIS).
• Any neurological level of injury.

You may not qualify if:

• Use of probiotics one-month prior admission.
• Use of immunomodulatory drugs one-month prior admission.
• Major gastrointestinal surgery in the last five years.
• Active gastrointestinal diseases.
• Other CNS diseases (besides SCI).

Sponsors & Collaborators

• Department of Medical Sciences, University of Aveiro: collaborator
• Centro de Reabilitacao do Norte: collaborator
• Centro Academico Clínico Egas Moniz Health Alliance: collaborator
• Aveiro Institute of Biomedicine (iBiMED): collaborator
• Unidade Local de Saude de Gaia e Espinho EPE: collaborator
• Prof. Sandra Vieira: lead

Study Sites (1)

Centro de Reabilitação do Norte (CRN) / Unidade Local de Saúde Gaia e Espinho, E.P.E. (ULSGE), Vila Nova de Gaia,, Portugal

Vila Nova de Gaia, 4405-565 Vila Nova de Gaia, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and fecal samples

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sandra I. Vieira, Prof. Dr.

  Institute of Biomedicine, Department of Medical Sciences, University of Aveiro (iBiMED-UA)

  PRINCIPAL INVESTIGATOR

• Maria Ribeiro da Cunha, MD

  Centro de Reabilitação do Norte (CRN)/Unidade Local de Saúde de Gaia e Espinho, E.P.E. (ULSGE)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Sandra I. Vieira

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: February 3, 2026
• Study Start: May 1, 2021
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

PT (1)